Takamatsu Naoki, Nakashima Misuzu, Matsuura Kei, Umemoto Ikue, Ito Masaya, Kanazawa Junichiro, Tomiyama Hirofumi, Kondo Masaki, Tachimori Hisateru, Nakao Tomohiro, Horikoshi Masaru, Kuga Hironori
National Center of Neurology and Psychiatry Tokyo Japan.
National Hospital Organization Hizen Psychiatric Center Yoshinogari Japan.
PCN Rep. 2024 Dec 2;3(4):e70036. doi: 10.1002/pcn5.70036. eCollection 2024 Dec.
Attention-deficit/hyperactivity disorder (ADHD) symptoms, including executive function, emotional regulation, and motivation, can persist into adulthood and are often associated with mental illnesses. Cognitive behavioral therapy (CBT) may help ADHD adults in Japan, but the lack of studies and the variability in group CBT approaches make its effects unclear. Japan lacks unified CBT programs and adult ADHD guidelines, making it difficult to implement international individual CBT recommendations due to cultural differences. This study will assess the feasibility of a novel CBT program for Japanese adult ADHD patients.
This feasibility study will be open, nonrandomized, single-arm, multicenter study. Twelve ADHD patients aged 20-65 years who are currently receiving treatment will be included based on Conners' Adult ADHD Rating Scale (CAARS) clinical severity threshold. An intervention phase of 12-16 weeks and a 12-week follow-up will total 24-28 weeks for all participants. The intervention will use a new CBT program tailored to individual assessments.
The primary objective is to determine feasibility using dropout rates, adverse events, and CAARS score changes between Weeks 1 and 16. The secondary outcomes will assess long-term effects of treatment beyond the intervention period and provide descriptive statistics on sex, depression, quality of life, and autistic scores in relation to the intervention outcomes. The full analysis set and per protocol set will be used for statistical analysis.
This study is essential for the development of CBT interventions in accordance with Japan's healthcare system that are tailored to the unique needs of its population.
注意力缺陷多动障碍（ADHD）的症状，包括执行功能、情绪调节和动机，可持续至成年期，且常与精神疾病相关。认知行为疗法（CBT）可能对日本的成年ADHD患者有所帮助，但相关研究的缺乏以及团体CBT方法的可变性使得其效果尚不清楚。日本缺乏统一的CBT项目和成人ADHD指南，由于文化差异，难以实施国际上的个体CBT建议。本研究将评估一种针对日本成年ADHD患者的新型CBT项目的可行性。
本可行性研究将是一项开放、非随机、单臂、多中心研究。根据康纳斯成人ADHD评定量表（CAARS）的临床严重程度阈值，纳入12名年龄在20 - 65岁且目前正在接受治疗的ADHD患者。所有参与者的干预阶段为12 - 16周，随访12周，总计24 - 28周。干预将使用根据个体评估量身定制的新CBT项目。
主要目标是通过脱落率、不良事件以及第1周和第16周之间的CAARS评分变化来确定可行性。次要结果将评估干预期之外治疗的长期效果，并提供与干预结果相关的性别、抑郁、生活质量和自闭症评分的描述性统计数据。完整分析集和符合方案集将用于统计分析。
本研究对于根据日本医疗保健系统开发适合其人群独特需求的CBT干预措施至关重要。
